System manufacturer : all persons (physical or moral) reassembling devices with a CE marking, depending on their destination and the limitations of use granted by their manufacturers, in order to launch them as a system or a kit (art. 7 of the Royal Decree dated 18/03/1999 (French version) ).

These manufacturers must give notification by using the notification form  (art. 10 of the Royal Decree dated 18/03/1999 (French version) ).

If the system or kit contains devices which don’t have a CE marking, or if the chosen combination of devices is not compatible, because the use originally planned for this devices was different, the system or kit is considered as device in its own right and, as such, is subject to the relevant procedure for checking that it conforms with article 5 of the Royal Decree dated 18/03/1999 (French version).

Contact :

Federal Agency for Medicines and Health Products 
Health Products Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Fax : +32 (0)2 524 81 20

Email :

Last updated on 16/12/2020